Treatment of Lambert-Eaton Syndrome With 3, 4-Diaminopyridine
18 Years
N/A
Both
Lambert Eaton Myasthenic Syndrome
Trial Information
Treatment of Lambert-Eaton Syndrome With 3, 4-Diaminopyridine
Patients with clinically-confirmed LEMS will receive 3, 4 DAP by mouth in slowly increasing
doses. Treatment will begin with 5 mg, three times a day and will increase by 50% every two
weeks to 10-15 mg, three to six times a day, as clinically needed, and if tolerated.
Patients will be monitored for strength and side effects via routine out-patient clinic
visits at initial intervals of 1 month, increasing to intervals of 6 months as permitted.
Subjects will be asked to temporarily stop study drug to determine if there is a return of
symptoms and need for continued treatment with 3, 4 DAP. Results of treatment and adverse
events will be reported to the FDA. Treatment will be continued indefinitely if a good
clinical response is achieved and side effects are tolerable.
Inclusion Criteria:
- Be 18 years or older, diagnosed with LEMS
- If female, have negative pregnancy test and if premenopausal, be willing to
practice an effective form of birth control during the study.
Exclusion Criteria:
- Is known to have a sensitivity to 3, 4 DAP
- Has a history of past or current seizures
- Has a history of past or current severe asthma
- Is believed by the investigator to be unable to comply with the protocol
- Unable to give informed consent
Type of Study:
Expanded Access
Study Design:
N/A
Principal Investigator
David Richman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, Davis
Authority:
United States: Food and Drug Administration
Study ID:
200311036
NCT ID:
NCT00704925
Start Date:
January 2000
Completion Date:
June 2011
Related Keywords:
- Lambert Eaton Myasthenic Syndrome
- Lambert Eaton Myasthenic Syndrome
- 3,4 DAP
- 3,4 Diaminopyridine
- Lambert-Eaton Myasthenic Syndrome
Name | Location |
|---|---|
| University of California, Davis | Sacramento, California 95818 |
